Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine
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|ClinicalTrials.gov Identifier: NCT04691908|
Recruitment Status : Completed
First Posted : December 31, 2020
Last Update Posted : July 26, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Covid19 SARS-CoV Infection Vaccine Adverse Reaction||Biological: QazCovid-in®-vaccine against COVID-19 Other: Placebo||Phase 3|
The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher increase in antibody titers to SARS-CoV-2) on the 21st, 42nd day, 90th and 180th days after vaccination.
To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo.
Evaluate vaccine efficacy.
Evaluate the safety of vaccine versus placebo.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Multicenter, Randomized, Blind, Placebo-controlled Clinical Study of III Phase on Assessment of Preventive Efficiency, Safety and Immunogenicity QazCovid-in®-Vaccine Against COVID-19 in Healthy Adult Volunteers|
|Actual Study Start Date :||December 25, 2020|
|Actual Primary Completion Date :||April 26, 2021|
|Actual Study Completion Date :||July 11, 2021|
Active Comparator: Phase III Adult-vaccine (A Sample, blind study)
Group 1 (phase III): 2400 volunteers from 18 years old and elder who will be the QazCovid-in® twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
Biological: QazCovid-in®-vaccine against COVID-19
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
Placebo Comparator: Phase III Adult-Placebo (A Sample, blind study)
Group 1 (phase III): 600 volunteers from 18 years old and elder who will be the Placebo twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
Placebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)
- Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2) [ Time Frame: at days 0, 21, 42, 90, 180 ]The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)
- To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo [ Time Frame: at days 0, 21, 42, 90, 180 ]The geometric mean titer of serum antibodies ELISA to SARS-CoV-2 after vaccination. The multiplicity of the change in the geometric mean titer of serum antibodies to SARS-CoV-2 after vaccination.
- Frequency of confirmed cases of COVID-19 [ Time Frame: through study completion, an average of 6 months ]The presence of clinical manifestations and a positive laboratory test for SARS-CoV-2 virus RNA within 6 months after vaccination
- Changing of antigen-specific cellular immunity level [ Time Frame: at days 0, 90, 180 ]Determination of the level of production of intracellular cytokines by antigen-activated T-lymphocytes
- Frequency of adverse events up to seven days after immunization [ Time Frame: Seven days after each immunization ]Frequency of adverse reaction in the seven days following each immunization per age group
- Frequency of adverse events up to 21 days after immunization [ Time Frame: 21 days after each immunization ]Frequency of adverse reaction in the 21 days following each immunization per age group
- Incidence of serious adverse events during the study [ Time Frame: throughout the study, an average of 6 months ]Incidence of serious adverse events during the study
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
Availability of signed and dated informed consent of the volunteer to participate in the study.
Healthy male and female volunteers aged 18 and above. Ability and voluntary desire to independently keep records in the Self-Observation Diary, as well as to carry out all the repeated visits provided for in the study for control medical observation.
The voluntary desire of females to use methods of reliable contraception throughout the entire period of their participation in the study.
Negative results for IgM and IgG antibodies to SARS-CoV-2. Absence of COVID-19 diagnosis in history. Absence in the last 14 days of close contact with persons suspected of being infected with SARS-CoV-2, or persons whose diagnosis of COVID-19 has been confirmed with laboratory.
Aggravated allergic history, drug intolerance, including hypersensitivity to any of the components of the study drug, as well as a history of serious adverse events during vaccine administration (such as allergic reactions, respiratory failure, angioedema, abdominal pain).
Acute illness with a fever (body temperature ≥37.1 ° C) at the time of screening.
History of chronic alcohol abuse and/or drug use. Positive results for antibodies IgM, IgG to SARS-CoV-2 Women with a positive urine pregnancy test. Simultaneous treatment with immunosuppressive drugs, incl. corticosteroids (2 weeks) 4 weeks prior to study drug administration.
Acute or chronic clinically significant lesions of the lungs, cardiovascular system, gastrointestinal tract, liver, blood system, skin, endocrine, neurological and psychiatric diseases or impaired renal function (asthma, diabetes, thyroid disease, arrhythmia, heart attack myocardium, severe hypertension not controlled by drugs, etc.), identified based on the data of the medical history, physical examination, which, according to the researcher, may affect the study result.
History of platelet disorder or other blood clotting disorders that may cause contraindications to intramuscular administration.
History of leukemia or neoplasm. Persons with autoimmune diseases. A history of Guillain-Barré syndrome or other neuroimmunological diseases. Subjects who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to study drug administration; Subjects who received anti-inflammatory drugs 2 days prior to study drug administration; Participation in any other clinical research within the last 6 months. Subjects with regard to whom there is a concern that they will not comply with the requirements of the study, or persons with severe physical or mental disabilities that may affect the completion of the study.
Voluntary refusal to study. Vulnerable research subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691908
|Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan|
|Gvardeyskiy, Jambul, Kazakhstan, 080409|
|Study Director:||Berik Khairullin, PhD||Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan|
|Study Chair:||Kunsulu Zakarya, PhD||Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan|
|Principal Investigator:||IIlyas Kulmagambetov, PhD||Centre for Clinical Medicine and Research|
|Responsible Party:||Research Institute for Biological Safety Problems|
|Other Study ID Numbers:||
|First Posted:||December 31, 2020 Key Record Dates|
|Last Update Posted:||July 26, 2021|
|Last Verified:||December 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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